France - POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, today announced its financial results for the period ended June 30, 2023 and provided a corporate update.
Thomas Kuhn, Chief Executive Officer of Poxel, stated: 'During the first semester of 2023, TWYMEEG strong sales momentum has been confirmed, with a total growth sales amount for the year 2022 that exceeded Sumitomo Pharma's forecast by 20%, and a 23% increase for the first quarter of Sumitomo Pharma fiscal year. This trend has been key to the success of our recent debt restructuring with our lenders. Our debt restructuring, along with the potential full drawdown of a new equity-linked financing with IRIS, extended our cash runway through Q2 2025. We are now concentrating our resources to actively work on other financing options to allow us to pursue our strategy in rare diseases, which includes the launch of Phase 2 proof-of-concept studies in this area, starting with adrenoleukodystrophy.'
First Half 2023 Key Events
Commercial Update
TWYMEEG (Imeglimin)
For the quarter ended June 2023, TWYMEEG gross sales in Japan increased 23% to JPY 1.16 billion (EUR 7.4 million)2 over the prior quarter sales of JPY 0.9 billion (EUR 6.2 million)2 as reported by Sumitomo Pharma.
The sales in recent quarters have accelerated due to the end of initial launch year restrictions for TWYMEEG in September 2022, which limited new products to two weeks prescriptions, and Sumitomo Pharma's commercial efforts to leverage TWYMEEG's potential. Thanks to its unique mechanism of action and safety profile, TWYMEEG can be used both as a monotherapy and in combination with other treatments, such as DPP4 inhibitors, the most prescribed treatment for Japanese Type-2-Diabetes patients, and SGLT2 inhibitors, which are growing strongly in Japan, and contribute to the increase in sales. These factors have resulted in a much higher increase in demand for TWYMEEG than expected by Sumitomo Pharma, and thus inventories are temporarily tight. Sumitomo Pharma is working diligently to increase the production and secure inventory capacity to meet this increasing demand.
For its FY 2023, Sumitomo Pharma announced a forecast for TWYMEEG of JPY 4.2 billion1 (EUR 28.9 million)3 which would represent a 90% increase over FY 2022 TWYMEEG gross sales.
For the Sumitomo Pharma FY 2023, as a conservative assumption in line with Sumitomo Pharma's forecast, Poxel expects to receive 8% royalties on TWYMEEG net sales. As part of the Merck Serono licensing agreement, Poxel will pay Merck Serono a fixed 8% royalty based on the net sales of TWYMEEG, independent of the level of sales.
During Sumitomo Pharma FY 2024 (ending March 31, 2025), Poxel expects TWYMEEG net sales in Japan to reach at least JPY 5 billion (EUR 34.4 million)3 entitling Poxel to receive 10% royalties on all TWYMEEG net sales (on which the first 8% will still be paid to Merck Serono) and a sales-based payment of JPY 500 million (EUR 3.4 million)3. Beyond Sumitomo Pharma FY 2024, Poxel expects to receive escalating double-digit royalties as well as additional sales-based payments upon achievement of contractually based sales thresholds. As per the debt restructuring agreements established with its lenders in March, positive net royalties and sales-based payments will be directed to Poxel debt reimbursement until the loans are fully repaid (which Poxel expects in Q2 2029, at the latest). After this time, subsequent net royalties and sales-based payments will revert back to Poxel.
As part of the Sumitomo Pharma's ongoing efforts to communicate TWYMEEG's unique mechanism of action and safety profile, 9 abstracts based on Imeglimin Phase 2b and Phase 3 clinical trials were accepted for oral presentations at the 66th Annual Meeting of the Japanese Diabetes Society (JDS), held in Kagoshima, Japan, May 11-13, 2023.
A Phase 4, 52-week, Open-label, Long-Term Study of Imeglimin in Japanese Type 2 Diabetic Patients with Renal Impairment is currently ongoing in Japan to strengthen TWYMEEG profile in this key subpopulation, and top line results are expected in 2024.
For territories not covered by its agreement with Sumitomo Pharma, Poxel is having active discussions with various potential partners for Imeglimin, in several countries. Those discussions also involve India, where local companies have received approval and have launched Imeglimin, in monotherapy only. At the date of this press release, no agreement has been established, and Poxel continues to be committed to asserting its rights in connection with its assets.
Rare metabolic diseases
In adrenoleukodystrophy (ALD), PXL770 and PXL065 are prepared to advance, subject to additional financing, into two Phase 2 biomarker proof-of-concept (POC) clinical trials in male patients with adrenomyeloneuropathy (AMN), the most common ALD subtype. The 12-week studies will evaluate pharmacokinetics, safety and potential for efficacy based on relevant disease biomarkers, such as the effect on very long chain fatty acids (VLCFA), the characteristic plasma marker of the disease.
In line with its mission, Poxel aims to bring therapeutic options to treat ALD, and supported the Alex Leukodystrophy Charity during their Community Weekend, which took place from April 28th to May 1st in Birmingham, England. This event brings together leukodystrophy sufferers and their families, alongside doctors, researchers and scientists from around the world to discuss leukodystrophies.
On June 23rd and 24th, Poxel participated virtually at the ULF (United Leukodystrophy Foundation) Scientific Symposium and Family Conference in Itasca, Illinois, USA. Sophie Bozec, Poxel Senior Vice President, R&D Pharmacology and Scientific Communication presented Poxel's status and plans for PXL770 and for the deuterium-modified TZD platform, using PXL065, based on robust scientific rationale and a complete preclinical package.
Corporate Update
On June 21st, the Company held its ordinary annual and extraordinary general meeting of shareholders. The shareholders approved all the resolutions that were recommended by the Board of Directors, including the renewal of Mr. Khoso Baluch, Mr. Thomas Kuhn et Ms. Pascale Boissel as Board members.
During the first semester, the Company pursued its corporate savings plan initiated in 2022 aiming at adapting the Company's resources to the current clinical development plan while preserving critical resources and competencies. At the date of this press release, there are 15 employees at Poxel compared to 37 at the end of December 2022.
Significant Events after the Period
On July 5th, Poxel was chosen as the winner of the 2023 edition of the I-nov contest for its program in ALD. Financed by the French State via the France 2030 plan, the prize of this contest includes a grant which will contribute in part4 in the financing of the two phase IIa proof-of-concept clinical studies for PXL770 and PXL065, which are ready to be launched, subject to additional funding, which the Company is actively working on.
In July 2023, the European Patent Office (EPO) granted Poxel a new patent for PXL065, a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone, which describes a specific form of PXL065 with unique properties. This recently issued patent provides additional protection through 2041, with the potential for an additional 5 years through patent term extension. In 2022, Poxel had been granted the same patent for PXL065 from the US Patent Office.
About Poxel SA
Poxel is a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare disorders. For the treatment of NASH, PXL065 (deuterium-stabilized R-pioglitazone) met its primary endpoint in a streamlined Phase 2 trial (DESTINY-1). In rare diseases, development of PXL770, a first-in-class direct adenosine monophosphate-activated protein kinase (AMPK) activator, is focused on the treatment of adrenoleukodystrophy (ALD) and autosomal dominant polycystic kidney disease (ADPKD). TWYMEEG (Imeglimin), Poxel's first-in-class product that targets mitochondrial dysfunction, is marketed for the treatment of type 2 diabetes in Japan by Sumitomo Pharma and Poxel expects to receive royalties and sales-based payments. Poxel has a strategic partnership with Sumitomo Pharma for Imeglimin in Japan, China, and eleven other Asian countries. Listed on Euronext Paris, Poxel is headquartered in Lyon, France, and has subsidiaries in Boston, MA, and Tokyo, Japan.
All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company's control. These statements may include, without limitation, any statements preceded by, followed by or including words such as 'target,' 'believe,' 'expect,' 'aim,' 'intend,' 'may,' 'anticipate,' 'estimate,' 'plan,' 'project,' 'will,' 'can have,' 'likely,' 'should,' 'would,' 'could' and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements. The Company does not endorse or is not otherwise responsible for the content of external hyperlinks referred to in this press release.
Contact:
Aurelie Bozza
Email: aurelie.bozza@poxelpharma.com
Tel: +33 6 99 81 08 36
POXEL 
